June 8th, 2020, by Labtoo's team
Activities of Research and Development have been severely impacted by the COVID-19 crisis. Biotech and pharmaceutical companies are starting to organize themselves to face the challenges raised by the pandemic on their clinical trials. Between financial, regulatory and policy implications, we sum up in this article the different consequences of the sanitary crisis on ongoing and future clinical trials.
What are the current consequences?
Many pharmaceutical and biotech companies have made the choice to temporarily stop their ongoing clinical trials. According to Labtoo’s survey, 85% of the researchers questioned have seen a partial or total postponement of their research projects in the clinical phase. Despite the possibility to continue them thanks to the new recommendations of regulatory agencies, stopping trials has been the only possible option for some companies.
Regulatory and policy agencies like the FDA or the EMA have indeed issued new guidelines related to clinical trials, including strategies on how companies can adapt to the current situation while reinforcing the essential need for any change to meet acceptable standards in patient safety and trial integrity. They have also communicated their intention to remain flexible in evaluating protocol changes and the resulting clinical data, as their goal is to provide a regulatory framework sufficient for trial sponsors to quickly adapt their protocols. However, this has not prevented the discontinuation of many clinical trials.
Clinical research stakeholders have reached the consensus that the impact of COVID-19 will be far-reaching, and analysis performed by Charles River Associates point towards severe consequences for trials comprising one or more of the following criteria:
- Enrolled vulnerable populations (including the elderly, the immunocompromised, and patients with pulmonary conditions),
- Have primary or secondary endpoints that require in-person visits or hospital infrastructure and equipment for assessment,
- Involve indications with minor safety or quality of life implications for patients and indications where a patient’s environment has a significant impact on therapeutic success (psychiatric and neurological indications for example),
- Are currently in the patient recruitment stage or are in phase I with healthy volunteers,
- Have trial sites located within hospitals or academic centers and in areas with high COVID-19 case density, potentially reducing the availability of staff to perform required activities and increasing the risk of adverse events and patient loss,
- Are evaluating immunosuppressive therapies or therapies that require complex and prolonged hospital visits,
- Involve smaller patient populations or people living with rare diseases.
While trial sponsors were primarily focused on trials that were in the recruitment or pre-recruitment stages at the very beginning of the pandemic, attention has now shifted to all trials, no matter their stages. Industry stakeholders have had to rapidly analyze the potential burdens of COVID-19 on data integrity and statistical power of their trials, in order to adapt their business strategy.
Future repercussion of the crisis
Upcoming consequences of COVID-19 on clinical research will primarily include financial, regulatory and policy implications requiring the implementation of new strategies never tried before.
About the financial impact of the crisis, small biotechs might face severe cash shortfalls and financing issues as a result of trial delays. Companies with a single asset could also be especially vulnerable. These stoppings and delays in clinical research might lead smaller companies to ask for additional funding and to make difficult financial cuts ; companies with high-value products may also be at a higher risk of acquisition. Delays will also lead to the postponement of product launches on the market, thus leading to shorter periods of patent exclusivity and lower benefits from launched products. Finally, these delays could also shift the competitive landscape in many therapeutic areas by allowing competitors to quickly adapt in response.
From a regulatory point of view, many research stakeholders have anticipated the requests from agencies for additional documentation on new protocols and procedures. However, this unexpected requirement has also been a challenge for many staffs responsible for trials and their sponsors, as inquiries from agencies necessitate quick replies. Travel restrictions and physical distancing measures have also generated deviations from initial protocols; and even if the FDA and EMA have announced that deviations that do not significantly impact the validity of the studies do not have to be reported, sponsors have to make sure their deviations meet this requirement.
Finally, the impact of the pandemic on clinical studies will also be felt on a policy level, especially during drug pricing negotiations. Additional delays for pricing negotiations could be observed, even for non-COVID-19 therapies.
All these factors have to be considered by trial sponsors in order to ensure study integrity and safety during this pandemic, while also thinking about the strategy to employ to minimize burdens of the crisis on their financial revenues. Besides reassessing their clinical research programs, companies have to reconsider their pricing policies and financing of their R&D pipeline; and the challenges raised by COVID-19 will surely have serious impacts on smaller biotechs that only have little room to maneuver. In any case, there is no doubt that companies that will quickly anticipate and adapt their strategies to these changes are likely the ones to have the strongest chances to succeed.